Back to resultsLong Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301)
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Valsartan + Amlodipine besilate
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Valsartan, Amlodipine, high blood pressure
Eligibility Criteria
Inclusion Criteria:
- Patients who successfully complete the core study (Study CVAA489A1301.
- Patients whose blood pressure at Visit 7 of the Study CVAA489A1301 had to be well controlled defined as MSDBP < 90 mmHg and MSSBP < 140 mmHg. At the investigator's or sub-investigator's discretion, those patients who were not well controlled (MSDBP ≥ 90 mmHg or MSSBP ≥ 140 mmHg), and whose MSDBP was < 100 mmHg and MSSBP was < 160 mmHg might participate in the extension if this was considered an acceptable level of blood pressure control for the patient.
- Male or female outpatients.
- Patients who have written informed consent to participate in this study.
Exclusion Criteria:
- Presence of major protocol violation in Study CVAA489A1301.
- Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301.
- Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301.
- Patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or sub-investigator.
- Patients who have gout or gouty arthritis.
- Patients hypersensitive to diuretics (except for potassium sparing diuretics).
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Valsartan + Amlodipine 80/5 mg
Valsartan + Amlodipine 80/5 mg + Diuretic
Arm Description
Valsartan 80 mg or Amlodipine 5 mg ---> Valsartan + Amlodipine 80 / 5 mg
Valsartan + Amlodipine 80 / 5 mg + Diuretic
Outcomes
Primary Outcome Measures
Safety assessed by serious and non-serious adverse events
No new unexpected AE's were observed in long-term treatment with VAA 80/5 mg. There were no deaths during the study. The SAEs were rare, with 9 patients (2.5%) reporting 10 events (1 patient experienced 2 SAEs). These events were not clustered to any particular primary system organ class and only 2 events the investigators could not excluded a relationship to study drug. The events that occurred were expected in this study population and/or were known to be associated with either valsartan or amlodipine. AEs leading to discontinuation occurred in 14 patients (3.8%).
Secondary Outcome Measures
Efficacy assessed by the changes-from baseline measurements in mean sitting diastolic blood pressure, mean sitting systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure
Clinically meaningful reductions in MSDBP and MSSBP were observed after 2 weeks of VAA 80/5 mg treatment and were maintained until the end of the 52-week VAA treatment period. The MSDBP and MSSBP were controlled below 85 mmHg and 130 mmHg, respectively for the entire 52-week VAA treatment period. At endpoint the MSDBP was controlled below 80 mmHg.
Laboratory tests
Laboratory changes observed with the long-term administration of VAA 80/5 mg were consistent with the known effects of each monotherapy agent.
Vital signs
Mean changes from baseline at endpoint were small and clinically unremarkable in extension population for weight, sitting/standing pulse values.
AEs related to abnormal vital signs were rare during the VAA treatment period. No patient reported orthostatic hypotension as an AE. Only one patient (PID 0045/00007) was discontinued from the study due to blood pressure decreased and dizziness.
Electrocardiogram (ECG)
None of the patients reported shifting from clinically non-significant to clinically significant ECG abnormality. However, three patients experienced clinically significant ECG abnormalities and were reported as AEs during the VAA treatment period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00446524
Brief Title
Long Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301)
Official Title
A 54-week Extension to the Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled, Factorial Study to Evaluate the Efficacy and Safety of VAA489 (Valsartan and Amlodipine Combined) and Alone in Essential Hypertensive Patients - Long Term Study of VAA489 in Patients With Essential Hypertension (Extension From A1301 Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate long-term safety and tolerability of once daily administration of the combination of Valsartan and Amlodipine 80/5 mg for 52 weeks in patients with essential hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Valsartan, Amlodipine, high blood pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
403 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valsartan + Amlodipine 80/5 mg
Arm Type
Experimental
Arm Description
Valsartan 80 mg or Amlodipine 5 mg ---> Valsartan + Amlodipine 80 / 5 mg
Arm Title
Valsartan + Amlodipine 80/5 mg + Diuretic
Arm Type
Experimental
Arm Description
Valsartan + Amlodipine 80 / 5 mg + Diuretic
Intervention Type
Drug
Intervention Name(s)
Valsartan + Amlodipine besilate
Other Intervention Name(s)
Valsartan, Amlodipine besilate, VAL, AML
Intervention Description
During the run-in period, either Valsartan 80 mg or Amlodipine 5 mg tablet was given once daily. Throughout the Valsartan + Amlodipine treatment period, a Valsartan + Amlodipine tablet 80/5 mg was given once daily at around 8:00 AM in the morning.
Primary Outcome Measure Information:
Title
Safety assessed by serious and non-serious adverse events
Description
No new unexpected AE's were observed in long-term treatment with VAA 80/5 mg. There were no deaths during the study. The SAEs were rare, with 9 patients (2.5%) reporting 10 events (1 patient experienced 2 SAEs). These events were not clustered to any particular primary system organ class and only 2 events the investigators could not excluded a relationship to study drug. The events that occurred were expected in this study population and/or were known to be associated with either valsartan or amlodipine. AEs leading to discontinuation occurred in 14 patients (3.8%).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Efficacy assessed by the changes-from baseline measurements in mean sitting diastolic blood pressure, mean sitting systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure
Description
Clinically meaningful reductions in MSDBP and MSSBP were observed after 2 weeks of VAA 80/5 mg treatment and were maintained until the end of the 52-week VAA treatment period. The MSDBP and MSSBP were controlled below 85 mmHg and 130 mmHg, respectively for the entire 52-week VAA treatment period. At endpoint the MSDBP was controlled below 80 mmHg.
Time Frame
12 months
Title
Laboratory tests
Description
Laboratory changes observed with the long-term administration of VAA 80/5 mg were consistent with the known effects of each monotherapy agent.
Time Frame
12 months
Title
Vital signs
Description
Mean changes from baseline at endpoint were small and clinically unremarkable in extension population for weight, sitting/standing pulse values.
AEs related to abnormal vital signs were rare during the VAA treatment period. No patient reported orthostatic hypotension as an AE. Only one patient (PID 0045/00007) was discontinued from the study due to blood pressure decreased and dizziness.
Time Frame
12 months
Title
Electrocardiogram (ECG)
Description
None of the patients reported shifting from clinically non-significant to clinically significant ECG abnormality. However, three patients experienced clinically significant ECG abnormalities and were reported as AEs during the VAA treatment period.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who successfully complete the core study (Study CVAA489A1301.
Patients whose blood pressure at Visit 7 of the Study CVAA489A1301 had to be well controlled defined as MSDBP < 90 mmHg and MSSBP < 140 mmHg. At the investigator's or sub-investigator's discretion, those patients who were not well controlled (MSDBP ≥ 90 mmHg or MSSBP ≥ 140 mmHg), and whose MSDBP was < 100 mmHg and MSSBP was < 160 mmHg might participate in the extension if this was considered an acceptable level of blood pressure control for the patient.
Male or female outpatients.
Patients who have written informed consent to participate in this study.
Exclusion Criteria:
Presence of major protocol violation in Study CVAA489A1301.
Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301.
Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301.
Patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or sub-investigator.
Patients who have gout or gouty arthritis.
Patients hypersensitive to diuretics (except for potassium sparing diuretics).
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigative Site
City
Fukuoka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Long Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301)
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